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Senior Manager Regulatory Affairs, Strategy
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Senior Manager Regulatory Affairs, Strategy
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Inozyme Pharma Boston, United StatesSenior Manager/Associate Director, Regulatory Strategy · Company Overview: · Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vascula ...
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AstraZeneca, plc Boston, United StatesThis is what you will do:Developing and implementing US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical Regulatory Affairs, Developmen ...
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AstraZeneca Boston, United StatesDirector, Global Regulatory Affairs, Development Strategy · This is what you will do: · Developing and implementing US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients wit ...
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Senior Director Regulatory Affairs Strategy
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EPM Scientific Boston, United StatesOur client, a clinical stage biotech company, is seeking an experienced and dynamic Director of Regulatory Affairs to join their team. This exciting opportunity offers the chance for someone with clinical regulatory lead experience and Oncology experience to take on a leadership ...
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Senior Manager Regulatory Affairs, Strategy
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Inozyme Pharma Boston, United StatesSenior Manager/Associate Director, Regulatory Strategy · Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants. · Company Overview: · Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopha ...
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BioSpace Boston, United StatesJob Details · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all inf ...
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BioSpace, Inc. Boston, United StatesJob Details · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all in ...
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Vice President, Head of Medical Affairs
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Apsida Life Science Boston, United StatesTitle: Vice President, Head of Medical Affairs · Location: Boston, MA · Overview: · Our client is a pioneering clinical-stage biopharmaceutical company dedicated to transforming the lives of patients with cardiovascular diseases. They are at the forefront of innovative research ...
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Vice President, Patient Affairs
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Sr. Director of Regulatory Affairs
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EPM Scientific Boston, United StatesResponsibilities: · Regulatory Strategy Development: Develop and implement comprehensive regulatory strategies to support the development, registration, and commercialization of oncology products in domestic and international markets.] · Regulatory Submissions: Oversee the prepar ...
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Director Clinical Operations
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Principal Regulatory Specialist
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Amplitude Vascular Systems Boston, United StatesDuties and Responsibilities: · Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing. · Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/acc ...
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Director Global Market Access
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Vertex Pharmaceuticals Boston, United StatesAbout the job · Job Description · Vertex operates at the forefront of scientific innovation and has successfully developed and commercialized multiple breakthrough medicines for Cystic Fibrosis (CF) as well as Casgevy, a new gene therapy for sickle cell disease and beta-thalassem ...
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VP, Early Clinical Development
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VP, Hematology, Clinical Development
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Rbw Consulting Boston, United StatesA clinical-stage biopharmaceutical company based in Boston, MA has an exciting pipeline in genetically defined rare diseases in areas of high unmet medical need. They are seeking a VP, Hematology, Clinical Development to take their lead asset in sickle cell forward and to further ...
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Principal Scientist, Clinical Biomarker
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Global Head of Clinical Operations
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Clinical Operations Analyst
3 days ago
Medasource Boston, United StatesClinical Operations Analyst · Boston, Massachusetts (Hybrid) · 1 year contract with likelihood of extension · Project Goal & Overview: · Our client is seeking a highly experienced Senior Clinical Analyst to lead and execute enterprise initiatives for clinical operations teams. A ...
Senior Director Regulatory Affairs Strategy - Boston, United States - EPM Scientific
Description
Our client, a clinical stage biotech company, is seeking an experienced and dynamic Director of Regulatory Affairs to join their team. This exciting opportunity offers the chance for someone with clinical regulatory lead experience and Oncology experience to take on a leadership role within this rapidly growing organization.
Responsibilities:
Lead interactions with Health Authorities and partners
Ensure cross-functional alignment among stakeholders involved during key steps across multiple projects simultaneously
Provide preparation of submission to global health authorities including IND, BLA, CTA, Orphan Drug Designation.
Assist project leaders by providing guidance regarding US/EU/ROW biocompatibility requirements, testing strategy/design/etc.
-Review study protocols and clinical study reports
Qualifications:
Bachelor's or Master's degree in relevant field
10+ years' experience working within the biopharma industry
-Understanding of Oncology Cell Therapy and Biologics
Clinical development knowledge required